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Clearance of Asymptomatic Pharyngeal Carriage of Neisseria Gonorrhoeae With or Without Ceftriaxone Treatment: Randomized Non-inferiority Study (PORTAPHAR)

Primary Purpose

Neisseria Gonorrhoeae Infection, Asymptomatic Pharyngeal Carriage

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Absence of antibiotic treatment
Ceftriaxone
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Neisseria Gonorrhoeae Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Patients (n=154): Patient inclusion criteria : Adult patient (age ≥ 18 years old) Patient consulting for a pharyngeal Neisseria gonorrhoeae Sexually Transmitted Infection (STI) and meeting the following criteria : Positive sample for NAAT by PCR in the pharynx for Neisseria gonorrhoeae dating back a maximum of 7 days (the date of the sample and those of inclusion will be compared) and asymptomatic patient Absence of symptoms of other bacterial STIs or other asymptomatic bacterial STIs confirmed on the systematic screening assessment carried out within 7 days before inclusion Patient's agreement to use protection or abstinence from all oral sex for 3 months follow-up (experimental group) or for 7 days (control group) For men whose female partner(s) are of childbearing age and for women of childbearing age: use of effective contraception (failure rate less than 1% per year) throughout research Patient benefiting from a social health security scheme Patient having signed a free and informed consent Patients non-inclusion criteria : Minor patient Symptomatic patient in the pharynx Presence of symptoms of another bacterial STI or of an asymptomatic bacterial STI confirmed on the screening report carried out within 7 days before inclusion Antibiotic treatment that may be active on Neisseria gonorrhoeae (C3G, Fluoroquinolones, Macrolides, Cyclins, Aminosides, Penicillins) within 14 days before inclusion Hypersensitivity to ceftriaxone, other cephalosporins or to any of the excipients History of severe hypersensitivity (e.g. anaphylactic reaction) to another class of antibacterial agents of the beta-lactam family (penicillins, monobactams and carbapenems). Contraindication to ceftriaxone Contraindication to intramuscular injections Person under legal protection, under guardianship or curatorship, person deprived of liberty, under safeguard of justice, subject to psychiatric care, under duress, admitted to a health or social establishment for purposes other than those of research Pregnant or breastfeeding woman Lack of social health insurance Patient included in another interventional study Partners (n=100) : Partner Inclusion Criteria : Sexual contact of the index case (genito-anal or genito-vaginal, oro-genital or oro-anal or oro-oral relations) in the month preceding the inclusion of the index case Adult patient (age ≥ 18 years old) Patient benefiting from a social health security scheme Patient having signed a free and informed consent Partner non-inclusion Criteria: Minor patient Person under legal protection, under guardianship or curatorship, person deprived of liberty, under safeguard of justice, subject to psychiatric care, under duress, admitted to a health or social establishment for purposes other than those of research Patient included in another interventional study Pregnant or breastfeeding woman

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Patients : Absence of antibiotic treatment

    Patients : Ceftriaxone

    Arm Description

    Outcomes

    Primary Outcome Measures

    Proportion of patients with a negative pharyngeal nucleic acid amplification test (NAAT) for Neisseria gonorrhoeae (NG)

    Secondary Outcome Measures

    Proportion of patients with a negative pharyngeal nucleic acid amplification test (NAAT) and a negative pharyngeal culture for Neisseria gonorrhoeae (NG)
    Proportion of patients with negative pharyngeal NG cultures
    Proportion of patients carrying methicillin-resistant Staphylococcus aureus (MRSA)
    Impact of ceftriaxone on the carriage of methicillin-resistant Staphylococcus aureus (MRSA) on the pharyngeal sample
    Proportion of patients carrying extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae
    Impact of ceftriaxone on the carriage of extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae on the anal sample
    Proportion of patients carrying methicillin-resistant Staphylococcus aureus (MRSA)
    Impact of ceftriaxone on the carriage of methicillin-resistant Staphylococcus aureus (MRSA) on the pharyngeal sample and extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae on the anal sample
    Proportion of patients carrying extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae
    Impact of ceftriaxone on the carriage of extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae on the anal sample
    Proportion of patients with spontaneous pharyngeal clearance of NG
    Analysis of factors associated with spontaneous pharyngeal clearance of NG : Socio-demographic and behavioural characteristics Amount of NG in the pharynx assessed by exploratory semi-quantitative PCR Bactericidal activity of anti-gonococcal antibodies and the production of specific anti-gonococcal antibodies in pharyngeal secretions
    Proportion of patients with spontaneous pharyngeal clearance of NG
    Analysis of the factors associated with spontaneous pharyngeal clearance of NG : Socio-demographic and behavioural characteristics Amount of NG in the pharynx assessed by exploratory semi-quantitative PCR Bactericidal activity of anti-gonococcal antibodies and the production of specific anti-gonococcal antibodies in pharyngeal secretions
    Proportion of partners with NAAT positive for NG
    Proportion of partners with NAAT positive for NG on at least one of the three sites of infection (pharyngeal, anal, first-void urine or vaginal self-sampling)
    Proportion of partners with NG cultures positive
    Proportion of partners with NG cultures positive on at least one of the three sites of infection (pharyngeal, anal, first-void urine or vaginal self-sampling)
    Proportion of partners with NAAT positive for NG
    Proportion of partners with NAAT positive for NG on at least one of the three sites of infection (pharyngeal, anal, first-void urine or vaginal self-sampling)
    Proportion of partners with NG cultures positive
    Proportion of partners with NG cultures positive on at least one of the three sites of infection (pharyngeal, anal, first-void urine or vaginal self-sampling)
    Proportion of partners with NAAT positive for NG
    Proportion of partners with NAAT positive for NG on at least one of the three sites of infection (pharyngeal, anal, first-void urine or vaginal self-sampling)
    Proportion of partners with NG cultures positive
    Proportion of partners with NG cultures positive on at least one of the three sites of infection (pharyngeal, anal, first-void urine or vaginal self-sampling)
    Proportion of identical genome between partner and patient
    Proportion of patients with Resistant NG strains
    Proportion of partners with Resistant NG strains
    Proportion of adverse events

    Full Information

    First Posted
    April 14, 2023
    Last Updated
    July 24, 2023
    Sponsor
    Assistance Publique - Hôpitaux de Paris
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05971550
    Brief Title
    Clearance of Asymptomatic Pharyngeal Carriage of Neisseria Gonorrhoeae With or Without Ceftriaxone Treatment: Randomized Non-inferiority Study
    Acronym
    PORTAPHAR
    Official Title
    Clearance of Asymptomatic Pharyngeal Carriage of Neisseria Gonorrhoeae With or Without Ceftriaxone Treatment: Randomized Non-inferiority Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    December 2025 (Anticipated)
    Study Completion Date
    December 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Assistance Publique - Hôpitaux de Paris

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Since the use of antibiotics, Neisseria Gonorrhoeae (NG) has acquired progressive resistance to penicillins, sulfonamides, tetracyclines and quinolones. The oropharynx is recognized as an important site for DNA exchange between NG and other commensal Neisseria, allowing NG to acquire new antimicrobial resistance. Despite the worrying data on the emergence of resistant NG, the recommendations remain to systematically treat these infections with ceftriaxone, including asymptomatic pharyngeal localizations. The objective of our study is to evaluate a ceftriaxone sparing strategy in order to limit the emergence of antibiotic resistance. The primary objective of the study is to evaluate the clearance of Neisseria gonorrhoeae, 3 months after the diagnosis of asymptomatic pharyngeal carriage documented on nucleic acid amplification test (NAAT).
    Detailed Description
    Non-inferiority, multicenter, prospective, randomized open-label study, in two parallel arms, comparing the pharyngeal clearance of Neisseria gonorrhoeae (NG) at 3 months with or without treatment with ceftriaxone. Experimental group: Absence of antibiotic treatment for at most 3 months after screening for asymptomatic NG pharyngeal infection (treatment if onset of symptoms related to Sexually Transmitted Infection or positive Polymerase chain reaction (PCR) at 3 months) Control group: Ceftriaxone 1000 mg by parenteral intramuscular route, in a single dose, according to the national recommendations in force, to be repeated if pharyngeal Polymerase chain reaction (PCR) again positive for NG during follow-up.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neisseria Gonorrhoeae Infection, Asymptomatic Pharyngeal Carriage

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    254 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Patients : Absence of antibiotic treatment
    Arm Type
    Experimental
    Arm Title
    Patients : Ceftriaxone
    Arm Type
    Active Comparator
    Intervention Type
    Other
    Intervention Name(s)
    Absence of antibiotic treatment
    Intervention Description
    Absence of antibiotic treatment for at most 3 months after screening for asymptomatic NG pharyngeal infection (treatment if onset of symptoms related to STI or positive PCR at 3 months)
    Intervention Type
    Drug
    Intervention Name(s)
    Ceftriaxone
    Intervention Description
    Ceftriaxone 1000 mg by parenteral intramuscular route, in a single dose, according to the national recommendations in force, to be repeated if pharyngeal PCR again positive for NG during follow-up
    Primary Outcome Measure Information:
    Title
    Proportion of patients with a negative pharyngeal nucleic acid amplification test (NAAT) for Neisseria gonorrhoeae (NG)
    Time Frame
    3 months after inclusion
    Secondary Outcome Measure Information:
    Title
    Proportion of patients with a negative pharyngeal nucleic acid amplification test (NAAT) and a negative pharyngeal culture for Neisseria gonorrhoeae (NG)
    Time Frame
    at 1 month after inclusion
    Title
    Proportion of patients with negative pharyngeal NG cultures
    Time Frame
    at 3 months after inclusion
    Title
    Proportion of patients carrying methicillin-resistant Staphylococcus aureus (MRSA)
    Description
    Impact of ceftriaxone on the carriage of methicillin-resistant Staphylococcus aureus (MRSA) on the pharyngeal sample
    Time Frame
    at 1 month after inclusion
    Title
    Proportion of patients carrying extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae
    Description
    Impact of ceftriaxone on the carriage of extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae on the anal sample
    Time Frame
    at 1 month after inclusion
    Title
    Proportion of patients carrying methicillin-resistant Staphylococcus aureus (MRSA)
    Description
    Impact of ceftriaxone on the carriage of methicillin-resistant Staphylococcus aureus (MRSA) on the pharyngeal sample and extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae on the anal sample
    Time Frame
    at 3 months after inclusion
    Title
    Proportion of patients carrying extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae
    Description
    Impact of ceftriaxone on the carriage of extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae on the anal sample
    Time Frame
    at 3 months after inclusion
    Title
    Proportion of patients with spontaneous pharyngeal clearance of NG
    Description
    Analysis of factors associated with spontaneous pharyngeal clearance of NG : Socio-demographic and behavioural characteristics Amount of NG in the pharynx assessed by exploratory semi-quantitative PCR Bactericidal activity of anti-gonococcal antibodies and the production of specific anti-gonococcal antibodies in pharyngeal secretions
    Time Frame
    at 1 month after inclusion
    Title
    Proportion of patients with spontaneous pharyngeal clearance of NG
    Description
    Analysis of the factors associated with spontaneous pharyngeal clearance of NG : Socio-demographic and behavioural characteristics Amount of NG in the pharynx assessed by exploratory semi-quantitative PCR Bactericidal activity of anti-gonococcal antibodies and the production of specific anti-gonococcal antibodies in pharyngeal secretions
    Time Frame
    at 3 months after inclusion
    Title
    Proportion of partners with NAAT positive for NG
    Description
    Proportion of partners with NAAT positive for NG on at least one of the three sites of infection (pharyngeal, anal, first-void urine or vaginal self-sampling)
    Time Frame
    At inclusion of the partner
    Title
    Proportion of partners with NG cultures positive
    Description
    Proportion of partners with NG cultures positive on at least one of the three sites of infection (pharyngeal, anal, first-void urine or vaginal self-sampling)
    Time Frame
    At inclusion of the partner
    Title
    Proportion of partners with NAAT positive for NG
    Description
    Proportion of partners with NAAT positive for NG on at least one of the three sites of infection (pharyngeal, anal, first-void urine or vaginal self-sampling)
    Time Frame
    at 1 month after inclusion of the partner
    Title
    Proportion of partners with NG cultures positive
    Description
    Proportion of partners with NG cultures positive on at least one of the three sites of infection (pharyngeal, anal, first-void urine or vaginal self-sampling)
    Time Frame
    at 1 month after inclusion of the partner
    Title
    Proportion of partners with NAAT positive for NG
    Description
    Proportion of partners with NAAT positive for NG on at least one of the three sites of infection (pharyngeal, anal, first-void urine or vaginal self-sampling)
    Time Frame
    at 3 months after inclusion of the partner
    Title
    Proportion of partners with NG cultures positive
    Description
    Proportion of partners with NG cultures positive on at least one of the three sites of infection (pharyngeal, anal, first-void urine or vaginal self-sampling)
    Time Frame
    at 3 months after inclusion of the partner
    Title
    Proportion of identical genome between partner and patient
    Time Frame
    Up to 3 months
    Title
    Proportion of patients with Resistant NG strains
    Time Frame
    Up to 3 months
    Title
    Proportion of partners with Resistant NG strains
    Time Frame
    Up to 3 months
    Title
    Proportion of adverse events
    Time Frame
    Up to 3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Patients (n=154): Patient inclusion criteria : Adult patient (age ≥ 18 years old) Patient consulting for a pharyngeal Neisseria gonorrhoeae Sexually Transmitted Infection (STI) and meeting the following criteria : Positive sample for NAAT by PCR in the pharynx for Neisseria gonorrhoeae dating back a maximum of 7 days (the date of the sample and those of inclusion will be compared) and asymptomatic patient Absence of symptoms of other bacterial STIs or other asymptomatic bacterial STIs confirmed on the systematic screening assessment carried out within 7 days before inclusion Patient's agreement to use protection or abstinence from all oral sex for 3 months follow-up (experimental group) or for 7 days (control group) For men whose female partner(s) are of childbearing age and for women of childbearing age: use of effective contraception (failure rate less than 1% per year) throughout research Patient benefiting from a social health security scheme Patient having signed a free and informed consent Patients non-inclusion criteria : Minor patient Symptomatic patient in the pharynx Presence of symptoms of another bacterial STI or of an asymptomatic bacterial STI confirmed on the screening report carried out within 7 days before inclusion Antibiotic treatment that may be active on Neisseria gonorrhoeae (C3G, Fluoroquinolones, Macrolides, Cyclins, Aminosides, Penicillins) within 14 days before inclusion Hypersensitivity to ceftriaxone, other cephalosporins or to any of the excipients History of severe hypersensitivity (e.g. anaphylactic reaction) to another class of antibacterial agents of the beta-lactam family (penicillins, monobactams and carbapenems). Contraindication to ceftriaxone Contraindication to intramuscular injections Person under legal protection, under guardianship or curatorship, person deprived of liberty, under safeguard of justice, subject to psychiatric care, under duress, admitted to a health or social establishment for purposes other than those of research Pregnant or breastfeeding woman Lack of social health insurance Patient included in another interventional study Partners (n=100) : Partner Inclusion Criteria : Sexual contact of the index case (genito-anal or genito-vaginal, oro-genital or oro-anal or oro-oral relations) in the month preceding the inclusion of the index case Adult patient (age ≥ 18 years old) Patient benefiting from a social health security scheme Patient having signed a free and informed consent Partner non-inclusion Criteria: Minor patient Person under legal protection, under guardianship or curatorship, person deprived of liberty, under safeguard of justice, subject to psychiatric care, under duress, admitted to a health or social establishment for purposes other than those of research Patient included in another interventional study Pregnant or breastfeeding woman
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Claire Pintado, Dr
    Phone
    +33142494973
    Email
    claire.pintado@aphp.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jérôme Lambert, Dr
    Phone
    +33142499742
    Email
    jerome.lambert@u-paris.fr

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Clearance of Asymptomatic Pharyngeal Carriage of Neisseria Gonorrhoeae With or Without Ceftriaxone Treatment: Randomized Non-inferiority Study

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